US Pharm. 2010;35(10):104-105.

Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh/measure each ingredient. Heat »20 mL purified water to 90°C and add the sodium benzoate; allow to cool to 40°C. In a separate container, add the citric acid to a small portion of the purified water. Combine the two solutions. Separately, disperse the xanthan gum in ~40 mL purified water at 65°C, allow to hydrate, then cool to room temperature. Combine the solutions. Add the potassium sorbate and sucrose; mix well. Separately, mix the albendazole with the polysorbate 80 and sorbitol; add to the solution. Add the simethicone, flavor (a mixture of orange and vanilla has been used), and sufficient purified water to volume; mix well. Package and label.

Use: Albendazole oral liquid is used as an anthelmintic in patients who cannot swallow the commercially available tablets.

Packaging: Package in tight, light-resistant containers.

Labeling: Shake well before taking. Keep out of the reach of children. Discard after ____ [time period].

Stability: As this preparation is commercially available in some countries, a beyond-use date (BUD) of up to 6 months may be used; however, a shorter BUD is generally recommended.1

Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).2

Discussion: Albendazole (C12H15N3O2S, MW 265.33), a synthetic benzimidazole-derivative anthelmintic agent, is structurally related to thiabendazole and mebendazole. It is used to treat tapeworm and roundworm infections. A white to faintly yellowish powder, it is practically insoluble in water and alcohol.2,3

Simethicone (dimethyl silicone fluid, polydimethylsiloxane, dimethicone, CH3[Si(CH3)2.O]nSi(CH3)3) occurs as a clear, colorless, odorless liquid. Simethicone is insoluble in water and alcohol.4

Polysorbate 80 (Tween 80, polyoxyethylene (20) sorbitan monooleate, C64H124O26) has an MW of 1,310. It occurs as a yellow oily liquid with a characteristic odor and a warm, somewhat bitter taste.5

Xanthan gum (corn sugar gum) is a high-MW polysaccharide gum that occurs as a cream- or white-colored, odorless, free-flowing, fine powder. It is soluble in cold or warm water.6

Sucrose (cane sugar, beet sugar, refined sugar, saccharose) is obtained from sugar cane, sugar beet, or other sources. It occurs as colorless crystals, crystalline masses or blocks, or a white, odorless crystalline powder with a sweet taste. Sucrose is soluble in water 1:0.5, alcohol 1:400, and 95% ethanol 1:170.7

Sorbitol (d-glucitol, C6H14O6, MW 182.17), a hexahydric alcohol, is isomeric with mannitol. It is an odorless, white or almost colorless, crystalline, hygroscopic powder.8

Sodium benzoate (C7H5NaO2, MW 144.11) occurs as a white granular or crystalline, slightly hygroscopic powder. It is soluble 1 g in 1.8 mL water and 75 mL 95% ethanol.9

Potassium sorbate (C6H7O2K, MW 150.22) occurs as a white, crystalline powder with a faint, characteristic odor. It is soluble in water (1 g in 1.72 mL), acetone (1 g in 1,000 mL), 95% alcohol (1 g in 35 mL), and propylene glycol (1 g in 1.8 mL).10

Citric acid (citric acid monohydrate, C6H8O7.H2O) occurs as colorless or translucent crystals or a white crystalline, efflorescent powder. One gram is soluble in less than 1 mL water and 1.5 mL ethanol.11

REFERENCES

1. USP Pharmacists’ Pharmacopeia. 2nd ed. Rockville, MD: U.S. Pharmacopeial Convention, Inc; 2008:775-779,1422.
2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
3. McEvoy GK. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010:50-52.
4. Sweetman SC, ed. Martindale: The Complete Drug Reference. 36th ed. London, England: Pharmaceutical Press; 2009:1770-1771.
5. Zhang D. Polyoxyethylene sorbitan fatty acid esters. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:549-553.
6. Shah HC, Singh KK. Xanthan gum. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:782-785.
7. Armstrong NA. Sucrose. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:703-707.
8. Shur J. Sorbitol. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:679-682.
9. Sakurai T. Sodium benzoate. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:627-629.
10. Quinn ME, Sheskey PJ. Potassium sorbate. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:579-581.
11. Amidon GE. Citric acid monohydrate. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:181-183.

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